Date of Enforcement Report 1/17/2018
Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures..
Recall Number Z-0258-2018 to Z-0261-2018
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user.
OrthoScan Inc., Scottsdale, AZ on 8/31/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally